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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Zimmer, Inc.
5791-49
In Commercial Distribution

  • 00889024192843 ()
00-5791-049-00

  • Orthopaedic prosthesis implantation positioning instrument, reusable
The PSG Adapter Cable is intended to interface the SenTec Digital Monitor to Polygraphs (PG) or Polysomnographs (PSG)
SenTec AG
PSG Cable G
In Commercial Distribution

  • 07640121880674 ()


  • Pulse Co-oximeter probe, reusable
  • Transcutaneous blood gas monitor sensor
  • Transcutaneous blood gas monitoring system
CBMT-DU-11A, F/G PN 74089-01M
RANFAC CORP.
11 Gauge x 4"
In Commercial Distribution

  • M9797408901M9 ()
  • M9797408901M0 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
CBMT-DU-11A

  • Bone marrow biopsy procedure kit
TRAY, BMET-11NL, F/G PN 74076-02M
RANFAC CORP.
11 Gauge x 4"
In Commercial Distribution

  • M9797407602M9 ()
  • M9797407602M0 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
BMET-11NL

  • Bone marrow biopsy procedure kit
TRAY, BMET-11, F/G PN 74076-01M
RANFAC CORP.
11 Gauge x 4"
In Commercial Distribution

  • M9797407601M9 ()
  • M9797407601M0 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
BMET-11

  • Bone marrow biopsy procedure kit
TRAY, BMET-11ANL, F/G PN 74075-02M
RANFAC CORP.
11 Gauge x 4"
In Commercial Distribution

  • M9797407502M9 ()
  • M9797407502M0 ()

  • Needle Gauge: 11 Gauge
  • Length: 4 Inch
BMET-11ANL

  • Bone marrow biopsy procedure kit
BMET-11A, F/G PN 74075-01M
RANFAC CORP.
11 GAUGE x 4"
In Commercial Distribution

  • M9797407501M9 ()
  • M9797407501M0 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
BMET-11A

  • Bone marrow biopsy procedure kit
Pak12G assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12G
Not in Commercial Distribution

  • 10888234500223 ()
PAK12G

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
No Description
G21 SRL
611-01-140
In Commercial Distribution

  • 08058964729026 ()


  • Orthopaedic cement, antimicrobial
No Description
G21 SRL
610-01-140
In Commercial Distribution

  • 08058964729019 ()


  • Orthopaedic cement, antimicrobial
Contains VT601US(ES,VS×2), 4 of cryotopUSs(Green)and Repro Plate
KITAZATO CORPORATION
VT601US-TOP(G)
In Commercial Distribution

  • 24582231462616 ()
  • 14582231462596 ()


  • IVF medium kit
Alegra Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
10259900
In Commercial Distribution

  • J021102599000 ()
  • J021102599001 ()


  • Dental surgical power tool motorized handpiece/set, electric
Alegra Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
10256630
Not in Commercial Distribution

  • J021102566300 ()
  • J021102566301 ()


  • Dental surgical power tool motorized handpiece/set, electric
Surgical Handpiece for 3I
W & H Dentalwerk Bürmoos GmbH
10207564
Not in Commercial Distribution

  • J021102075641 ()


  • Dental surgical power tool motorized handpiece/set, electric
Surgical Handpiece
W & H Dentalwerk Bürmoos GmbH
00001120
Not in Commercial Distribution

  • J021000011201 ()


  • Dental surgical power tool motorized handpiece/set, electric
T-MAT G/RA 50SH 8x10in film
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889978453931 ()
  • 40889978453937 ()
  • 00889978453939 ()
8453938

  • Dental x-ray film, screen
T-MAT G/RA Film 100SH 15x30cm
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889976468463 ()
  • 40889976468469 ()
  • 00889976468461 ()
6468466

  • Dental x-ray film, screen
T-MAT G/RA Film 50SH 12.7x30.5cm
CARESTREAM HEALTH, INC.
T-MAT G/RA
Not in Commercial Distribution

  • 60889976468456 ()
  • 40889976468452 ()
  • 00889976468454 ()
6468458

  • Dental x-ray film, screen
T-MAT G/RA 50SH 12.7x30.5cm film
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889971987624 ()
  • 40889971987620 ()
  • 00889971987622 ()
1987627

  • Dental x-ray film, screen
T-MAT G/RA 50SH 15x30cm film
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889971869081 ()
  • 40889971869087 ()
  • 00889971869089 ()
1869080

  • Dental x-ray film, screen
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system. In bone infection, CERAMENT G can also be inserted as pre-set beads.
Bone Support AB
A0535-06
In Commercial Distribution

  • 07350055430530 ()

  • Total Volume: 5 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system. In bone infection, CERAMENT G can also be inserted as pre-set beads.
Bone Support AB
A0535-05
In Commercial Distribution

  • 07350055430523 ()

  • Total Volume: 10 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads.
Bone Support AB
A0450-11
In Commercial Distribution

  • 07350055430394 ()

  • Total Volume: 5 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads.
Bone Support AB
A0450-10
In Commercial Distribution

  • 07350055430387 ()

  • Total Volume: 10 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
This nickel alloy can be veneered using most high melt ceramics.
Schütz Dental GmbH
622323
In Commercial Distribution

  • ESDG6223231 ()


  • Dental casting non-noble alloy
This nickel alloy can be veneered using most high melt ceramics.
Schütz Dental GmbH
622322
In Commercial Distribution

  • ESDG6223221 ()


  • Dental casting non-noble alloy
No Description
Cowellmedi Co.,Ltd
SGN453N
In Commercial Distribution

  • 08800016106862 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGH453N
In Commercial Distribution

  • 08800016106855 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGN452N
In Commercial Distribution

  • 08800016106800 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGH452N
In Commercial Distribution

  • 08800016106794 ()


  • Dental implant suprastructure, permanent, preformed
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